Search Results

The LASER THERMAL THERAPY KIT used to direct laser energy to soft tissue, to necrotize or coagulate soft tissue through interstitial irradiation in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vessels in the perical sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, orthopedics, pulmonology, radiology, and urology, at a wavelength of 1064nm.

The LASER THERMAL THERAPY KIT is used to transfer laser energy from the laser unit to the tissue site for the treatment. The LASER THERMAL THERAPY KIT consist of a Fiber Optic for PLA (272μm core quartz fiber with distal end outer diameter 420um and NA 0.2) and an introducer needle (21G). The device is sterile and single use.

The provided text describes a 510(k) summary for the "LASER THERMAL THERAPY KIT" by Elesta SpA. This document outlines the device's technical characteristics and claims substantial equivalence to existing predicate devices. However, it does not contain details about specific acceptance criteria and a study proving the device meets those criteria in terms of clinical performance or diagnostic accuracy.

The non-clinical performance tests mentioned focus on engineering aspects like laser light transmission, power loss, mechanical and optical functionalities, sterilization, shelf-life, and biocompatibility. These are essential for device safety and basic functionality but do not relate to clinical effectiveness or user performance against predefined clinical criteria.

Therefore, I cannot provide the requested information regarding clinical acceptance criteria and a study demonstrating the device meets them from the given text.

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance:

• Cannot be provided. The document does not define clinical acceptance criteria for the device's performance in terms of treatment outcomes or diagnostic accuracy. The "reported device performance" referred to in the text relates to engineering tests (e.g., effectiveness and efficiency of laser light transmission, power loss, mechanical/optical functionalities, sterilization, shelf-life, biocompatibility).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Cannot be provided. No clinical test set or data provenance is mentioned in the document. The tests described are engineering and laboratory-based.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Cannot be provided. No clinical test set, ground truth, or expert involvement is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Cannot be provided. No clinical test set or adjudication method is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Cannot be provided. This device is a laser thermal therapy kit, not an AI diagnostic or assistance tool for human readers. Therefore, an MRMC study is not applicable to its stated function, and no such study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Cannot be provided. This device is a hardware component (fiber optic and introducer needle) for delivering laser energy, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Cannot be provided. No clinical ground truth is discussed. The "ground truth" for the non-clinical tests would be the established engineering specifications and standards (e.g., power output measurements, ISO standards for sterilization).

8. The sample size for the training set:

• Cannot be provided. No training set for an algorithm is mentioned as this is a medical device hardware component.

9. How the ground truth for the training set was established:

• Cannot be provided. As above, no training set for an algorithm is mentioned.

In summary, the provided document focuses on substantiating equivalence to predicate devices based on design, intended use, technological characteristics, and non-clinical engineering and bench testing. It does not include information about clinical performance studies or specific acceptance criteria for treatment efficacy or diagnostic accuracy.

Ask a specific question about this device